(79 days)
The BIOSACA equipment is indicated for use in the recording, displaying, printing and storage of biological and non-biological signals for sleep monitoring, neurological disorder and epilepsy investigations as a visual aid to the physician. Biological signals include Electroencephalography (EEG), Electromyography (EMG), Electrooculography (EOG), Ballistocardiography, etc. BIOSACA is designed for both stationary and mobile operation and may be used in either the patient's home or the hospital. Biological signals are encountered which can be recorded directly from the patient. Non-biological signals are recorded using indirect methods such as flow of air (breathing), blood pressure, etc. The equipment is suitable for home use as the patient needs only a minimal amount of instructions for home use. The system has no lights or sounds that could confuse the patient. Signals may be stored for later analysis or may be viewed directly in conjunction with the recording. When monitoring, the operator sees the signals at the same time as they are recorded. The Biosaca unit is intended for use on an adult population and at home or in health care facilities. The unit is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
The BIOSACA is a multi-functional and an ambulatory recording device. It is a portable system for the recording, monitoring, storage and transfer of up to 22 bioparameters such as brain, heart and muscle activity, eye movement, blood pressure, breathing, body movements etc. There are applications for the BIOSACA in neurological, cardiology and sleep disorder diagnoses. The BIOSACA is a biological signal recorder able to receive and record up to 22 bioparameters - 16 from two headboxes, AC and/or DC, three from the pulse oximeter and three from the sensor pad.
Here's an analysis of the provided text regarding the Biosaca device, focusing on acceptance criteria and study information.
It's important to note that the provided documents (510(k) summary and FDA clearance letter) are regulatory documents, not a scientific study report. As such, they do not present detailed scientific study methods, acceptance criteria with numerical targets, or study results in the manner one would find in a peer-reviewed publication or a detailed clinical trial report. The 510(k) process primarily demonstrates substantial equivalence to predicate devices, focusing on similar intended use, technological characteristics, and safety/effectiveness profiles, rather than rigorously proving performance against pre-defined numerical thresholds in a clinical study.
Therefore, many of the requested details about specific acceptance criteria and study methods are either not explicitly stated or not applicable in the context of the provided materials.
Analysis of Biosaca Device Information
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the provided 510(k) summary does not contain specific, quantitative acceptance criteria or detailed device performance metrics typically found in a clinical study. The submission focuses on demonstrating substantial equivalence to predicate devices based on intended use and technological characteristics.
| Acceptance Criterion (Hypothetical for a typical performance study) | Reported Device Performance (Based on provided documentation) |
|---|---|
| Accuracy of Bioparameter Recording | The device is stated to be "a biological signal recorder able to receive and record up to 22 bioparameters" including EEG, ECG, EMG, EOG, blood pressure, breathing, and body movements. The 510(k) process suggests the device is considered substantially equivalent to predicate devices (Compumedics Sleep Monitoring System, Embla) for these recording functions, implying comparable accuracy. No specific numerical accuracy metrics (e.g., % agreement, sensitivity, specificity, measurement error) are provided. |
| Functional Equivalence to Predicate Devices | The core acceptance was FDA's determination of "substantial equivalence" to predicate devices (Compumedics Sleep Monitoring System, K955841; Embla, K971813) for the stated indications for use (recording, monitoring, display, print, store, and transfer bioparameters like brain, heart, muscle activity, eye movement, blood pressure, breathing, and body movements, for sleep monitoring, neurological disorder, and epilepsy investigations). This implies that its functionality and safety are comparable to these already marketed devices. No specific functional performance test results are included. |
| Safety | The device is not intended for life support and is suitable for home use, with minimal patient interaction and no confusing lights or sounds. The FDA clearance implies that the device has met general controls provisions related to safety (e.g., manufacturing practice, labeling). No direct safety study results or adverse event rates are reported in this summary. |
| Usability/Ease of Use (for home use) | "The equipment is suitable for home use as the patient needs only a minimal amount of training and it has no lights or sounds that could confuse the patient." This is a qualitative statement of intent and design, acting as an implicit "acceptance criterion." No formal usability study results are provided. |
| Compatibility/Interoperability | Accepts inputs from "two headboxes, AC and/or DC, three from the pulse oximeter and three from the sensor pad." This indicates its compatibility with standard physiological sensors. No specific compatibility test results (e.g., data format validation, signal integrity from different sensors) are detailed. |
| Regulatory Compliance | The FDA's substantial equivalence determination itself is the primary evidence that the device meets regulatory "acceptance criteria" for marketing in the US, subject to general controls. The letter confirms compliance with various regulatory requirements (e.g., registration, listing, manufacturing practice, labeling). No specific test results demonstrating compliance with particular standards (e.g., electrical safety, EMC) are listed here, though such testing would typically be part of a 510(k) submission. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified. The provided documents describe device characteristics and regulatory equivalence, not a clinical study involving a test set with human subjects.
- Data Provenance: Not applicable in the context of the provided text, as no specific test set data is presented. The 510(k) relies on comparison to predicate devices, which would have had their own historical data supporting their market clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable. No specific test set with ground truth established by experts is mentioned.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. No test set requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or implied by the provided documents. The Biosaca is a signal recorder, not an AI-assisted diagnostic tool that would typically involve human readers interpreting outputs.
- Effect Size: Not applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Standalone Performance Study: Not explicitly described as a formal study. The device itself performs data recording functions. Its "standalone" performance would relate to its ability to accurately capture and store bioparameters. The substantial equivalence determination suggests that its recording capabilities are comparable to predicate devices. However, no specific performance metrics from such a study are provided.
7. The Type of Ground Truth Used
- Type of Ground Truth: Not applicable. No specific ground truth for a performance study is described. The device's "ground truth" would be the actual physiological signals themselves, and the device's performance would be assessed by how accurately it records these signals. This level of detail is not in the provided documents.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The Biosaca is a hardware device for recording physiological signals. It does not appear to utilize machine learning or AI algorithms that would require a "training set" in the conventional sense. Its functionality is based on established electronics and signal processing principles.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set for machine learning.
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1
510(k) Summary K984580
Safety and effectiveness information concerning the Biosaca from Biosys AB is summarized below.
| Date Prepared | December 18, 1998 | ||
|---|---|---|---|
| Applicant | BIOSYS AB (publ)Vasaplatsen 8SE-411 34 GöteborgTelephone: +46 31 774 21 25Fax: +46 31 13 98 54e-mail: info@biosys.se | ||
| Contact | Anne Mari Nedevska, Technical Administration Manager | ||
| Device Name | BIOSACA | ||
| Common Name | Biological Signal Recorder | ||
| Classification | No formal classification name or number has been assigned for devices such as the Biosaca. Stand-alone devices for the same use as the Biosaca include the following: | ||
| Panel | Product Code | Name | 21 CFR |
| 84 | GWQ | Electroencephalograph | 882.1400 |
| 84 | GYE | Physiological telemetry system | 882.1855 |
| 84 | GWP | Electromyography | 882.5050 |
| 84 | LEL | Sleep Assessment Device | |
| 80 | FLS | Breathing frequency | 868.2375 |
| 73 | MNR | Ventilatory effort recorder | 868.2375 |
| 74 | DPS | Electrocardiography (ECG) | 870.2340 |
| 74 | DQA | Pulse Oximeter | 870.2700 |
| 73 | DRX | Electrocardiograph electrode | 870.2360 |
Błosys AB (publ).
Vasaplatsen B SE-411 34 Goteborg Telephone +46(0)31 774 21 25 Fax +46(0)31 13 98 54 E-mall info@blosys.se
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| Submission | |
|---|---|
| Correspondent | Jane B. CampbellJ. & D. Campbell Associates, Inc.485 LaRoe RoadChester, New York 10918Tel. 914-469-4289Fax. 914-469-4212e-mail: jdca@warwick.net |
| Predicate Devices | Compumedics Sleep Monitoring System, CompumedicsSleep Pty. Ltd (K955841)Embla, Flaga hf. (K971813) |
| Device Description | The BIOSACA is a multi-functional and an ambulatoryrecording device. It is a portable system for the recording,monitoring, storage and transfer of up to 22 bioparameterssuch as brain, heart and muscle activity, eye movement,blood pressure, breathing, body movements etc. There areapplications for the BIOSACA in neurological, cardiologyand sleep disorder diagnoses. |
| Function | The BIOSACA is a biological signal recorder able to receiveand record up to 22 bioparameters - 16 from two headboxes,AC and/or DC, three from the pulse oximeter and three fromthe sensor pad. |
| Intended Use | The intended use for the BIOSACA is to record, monitor,display, print, store and transfer bioparameters such as brain,heart and muscle activity, eye movement, blood pressure,breathing and body movements.The BIOSACA unit is intended to be used on an Adultpopulation and for use at home or in health care facilities. Itis not intended for use as life support equipment such as vitalsigns monitoring in intensive care units. The unit may beused for electrocardiography, electroencephalography,electromyography, electrooculography ballistocardiography |
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E-mall info@blosys.se
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002
Biosys AB c/o Jane B.Campbell J. D. Campbell Associates 485 Laroe Road Chester, New York 10918
APR - 9 2012
Re: K984580
Trade/Device Name: BIOSACA Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLV, DQA, GWQ, MNR Dated (Date on orig SE ltr): December 18, 1998 Received (Date on orig SE ltr): December 23, 1998
Dear Ms. Campbell:
This letter corrects our substantially equivalent letter of March 12, 1999.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Ms. Jane B.Campbell
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Enclosure
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Indications for Use Statement
K984580 510(k) Number (if known):
Device Name:
BIOSACA
Indications for Use:
:
. ..
The BIOSACA equipment is indicated for use in the recording, displaying, The BIOSACA equipment is materials increases and non-biological signals for sleep monitoring, printing and storage of otoroge of the conceptalography (EEG), disorder and epilepsy investigations as a visuality (EMG), Electrooculography (EOG), Ballistocardiography, etc. BIOSACA is designed for both stationary and (DOO), Ballisiocal diography, cood in either the patient's home or the hospital. mobile operation and may be toos an which can be recorded directly from the Blological siguals are encourted organis are recorded using indirect methods such as pation. Non-of air (breathing), blood pressure, etc.
The equipment is suitable for home use as the patient needs only a minimal amount I he equipment is surations for none setsem has no lights or sounds that could confuse the patient. Signals may be stored for later or may be viewed directly in contuse the patient. Sights may over . When monitoring, the operator sees the signals at the same time as they are recorded.
The Biosaca unit is intended for use on an adult population and at home or I he Diosaca alle is not intended for use as life support equipment such as vital signs monitoring in intensive care units.
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Concurrence of CDRH, Office of Device Evaluation
General Restorative Devices 9845 Am
Prescription Use (Per 21 CFR 801.109)
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).